NBMedNanotechnology for Biology and Medicine (graduate training program; Johns Hopkins University; Maryland)
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Two format guidances also worth reviewing were issued by the Team Notified Body NBMED and the Global Harmonization Task Force (GHTF) Study Group I (for more information, read "Euro News" in the March 2008 issue of MPO).
(The MDEG is composed of delegates from member state competent authorities and other EU well-known organizations including EUCOMED, EDMA, CEN, CENELEC, NBMED and EAAR.)
This may be another concept that is difficult to reconcile and reasonably well explained by the NB-MED guidance, which states: "Operation of software requires electrical energy and software functions by converting this energy by means of interfaces and or actuators, which are parts of the programmable electrical medical system." The NBMED guidance document is interesting, because it attempted to delineate some of the inadequacies of the European regulations with regards to software.